As expected, regulators in the USA have given the green light to Novartis' Afinitor as a treatment for a rare type of pancreatic cancer.
Specifically, the US Food and Drug Administration has approved Afinitor (everolimus) tablets for the treatment of progressive neuroendocrine tumours of pancreatic origin (PNET) in patients with unresectable, locally advanced or metastatic disease. Novartis noted that this marks the first approval for the disease in the USA in nearly 30 years.
The thumbs-up was based on Phase III data from the RADIANT-3 trial, showing treatment with Afinitor more than doubled the time without tumour growth (median 4.6 to 11.0 months) and reduced the risk of cancer progression by 65% when compared with placebo in patients with advanced PNET. A "consistent improvement" in progression-free survival was seen in all patient subgroups, though the FDA determined that the safety and effectiveness of Afinitor in patients with carcinoid tumours have not been established.
The approval was expected given that the FDA's Oncologic Drugs Advisory Committee voted unanimously (10-0) in favour of Afinitor for this indication last month. Herve Hoppenot, president of Novartis Oncology, noted that the decision is the third indication for Afinitor in the USA in just over two years, "providing further evidence that inhibiting mTOR [a protein that regulates tumour cell division, blood vessel growth and cell metabolism] plays an important role in treating multiple tumour types".
Afinitor is already approved in the USA for advanced kidney cancer in patients who do not benefit from Pfizer's Sutent (sunitinib) or Bayer's Nexavar (sorafenib) and for the treatment of patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis who are not candidates for curative surgical resection.